Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

This study has been completed.

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00963157

First Posted: August 21, 2009

Last Update Posted: December 24, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine Unadjuvanted

Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

15 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

15 mcg H1N1 Vaccine Unadjuvanted

Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine Unadjuvanted

Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

15 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

15 mcg H1N1 Vaccine Unadjuvanted

Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 8 after the first vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 8 after the first vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ]

Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 270 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ]

Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 270 after the second vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

Measure Description

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.

Time Frame

Day 0 prior to vaccination and 180 days after the second H1N1 vaccination

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups

Description

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

7.5 mcg H1N1 Vaccine Unadjuvanted

Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

15 mcg H1N1 Vaccine + AS03 Adjuvant

Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.

15 mcg H1N1 Vaccine Unadjuvanted

Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

7.5 mcg H1N1 Vaccine Unadjuvanted

15 mcg H1N1 Vaccine + AS03 Adjuvant

15 mcg H1N1 Vaccine Unadjuvanted

Participants Analyzed [Units: Participants]

98

103

99

96

97

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [Units: Participants]

82

83

56

79

65

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

33. Secondary:

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]